Healing shoe or sandal

ABSTRACT

A medical shoe for use in supporting a patient&#39;s foot and a method of using same, the medical shoe comprising an out sole, an upper assembly secured to and partially surrounded by the out sole and an insole assembly substantially enclosed by the outsole and the upper assembly. The outsole having a base portion generally corresponding with the plantar aspect of a human foot and of varying thickness and having a substantially rectangular opening in a top surface of the base portion thereof adapted for accommodating a metatarsal shank. The out sole having a circumferential counter portion extending upward circumferentially from the top surface of the base portion thereof around the base portion of the outsole thereby providing a cavity in the outsole. The upper assembly adapted to surround at least the heel, sides and dorsal portions of the human foot. The upper assembly attached to the top surface of the base portion of the outsole and the circumferential counter of the outsole, and extending in a dorsal direction from the top surface of the base portion of the outsole along the circumferential counter. The insole assembly having a plurality of insole layers disposed in the outsole cavity and surrounded by the upper assembly and the outsole circumferential counter. The plurality of insole layers provided to include a first insole layer, a second insole layer a third insole layer and a fourth insole layer wherein the first and second layers are an Ethyl Vinyl Acetate (EVA) material and the second layer has a durometer less than the first layer, the third layer is a Poron material with a durometer less than the second layer, and the fourth layer is an EVA material with a durometer less than the third layer, and the first, second, third, and fourth layers may be assembled in any order as determined by a health care provider.

This application is a national stage application of PCT/US01/11737,which was filed on Apr. 30, 2001, and which claims benefit to U.S.Provisional Application No. 60/201,758, which was filed on May 4, 2000.

BACKGROUND DESCRIPTION OF THE INVENTION

1. Field of the Invention

The present invention pertains to a shoe or sandal specifically designedto aid in the offloading, or reducing weight or pressure, from aspecific area of the foot. The shoe or sandal, and specifically theinsole and outer covering of the shoe upper, are designed to be alteredby or under the direction of the health care provider to either offloadweight from the bottom of the foot or to remove or reduce pressure fromthe sides, top or other specific areas of the foot.

The incidence of foot ulcers, infections and deformities of the feet hasbecome an increasing problem as the life expectancy of patients withdiabetes and other chronic diseases increase. The cost of treatment ofthese complex foot problems has escalated to the point that the Centerfor Disease Control and others in the health delivery system are placinga special emphasis on finding more effective ways of treating theseproblems. Patients with circulatory problems, diabetes, AIDS, arthritisneuropathies and other debilitating diseases experience complicationsthat lead to increased deformities in the feet subjecting the deformedareas to increased pressures and friction. Spinal cord injuries andother injuries to the back and lower extremities may cause neuropathiesthat in turn produce deformities in the toes and feet with a loss offeeling causing more complications to develop. Chemically inducedneuropathy from chemotherapy, alcohol, drug abuse, etc., may also leadto ulcerations and lesions of the feet that require special care. All ofthese problems are exacerbated by weight bearing pressure or frictionfrom conventional shoes. Regardless of how aggressive the treatmentplan, the use of expensive antibiotics, local wound care, surgery etc.,healing is delayed and the lesions and infections reoccur unlesseffective measures are taken to redistribute weight reducing pressureand friction from the involved foot lesions.

2. Description of the Related Art

Orthotics (othopedic inserts) for supporting certain aspects of thehuman foot are well known in the field of podiatric medicine. However,orthotics can produce added pressure on the supported areas and causerubbing which may lead to blistering or other ailments, complicating theabove-described problems. Orthotics require additional space when usedin conjunction with standard insoles and may even require extra spacewhen comprised in a customized insole. Thus, when used in normal massmarket shoes, orthotics can also cause rubbing on opposite surfaces ofthe foot, due to reduced clearance between foot and the shoe upper.Othopedic shoes such as those manufactured by Markell® and othersprovide extra depth to accommodate foot deformities and/or orthotics,but have an extremely awkward appearance, generally having a much higherprofile (taller appearance) than normal mass-market shoes, and can beunstable when multiple inserts are used.

The wound care shoe system is designed to produce a foot friendlyenvironment where pressure and friction are reduced allowing healing totake place and to reduce the incidence of reoccurrence of a lesion. Theinvention provides an easy to use healing shoe or sandal and aneffective method to offload weight from a particular area of the plantaraspect (bottom) of the human foot by using alterable insoles or insolelayers of varying densities and degrees of firmness which fit into anarea surrounded by a circumferential counter, in order to hold theinsole layers in position. This creates a low profile more stable shoethan prior art extra depth shoes. The outer covering of the upper isalso constructed of materials that can be cut out or heat molded orotherwise altered to reduce friction and/or pressure from the non-weightbearing areas of the foot.

SUMMARY OF THE INVENTION

The above and other objects of the invention, which will become apparenthereinafter, are achieved by the provision of an adjustable sandal orshoe with the upper constructed of a combination outer cover, preferablyof leather, with an inner liner preferably of EVA or Plastizote, orsimilar material. This upper permits small portions of the outer coverover a lesion or bony prominence to be cut away leaving the underlyingmoldable liner of EVA for protection without destroying the integrity ofthe shoe. This removes the friction and pressure from the area over thelesion permitting faster healing. An out sole, including a base portionhaving a rocker bottom and a circumferential counter are molded in onepiece providing a cavity with space for the various layers of insolematerial as well as stabilizing the insoles within the cavity of theoutsole. The insoles are fabricated of soft, medium and firm density EVAor other suitable materials that mold to the foot. Certain sections ofthe insoles can be ground down or cut away, to redistribute weight awayfrom a lesion or areas of excessive pressure. The insoles are eitherheat or pressure moldable. A fitting marker is also located on themedial side of the out sole in order to aid the health care provider inproper shoe fitting.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top and front elevation of the wound care sandal or shoeforming a preferred embodiment.

FIG. 2 is a medial side elevation of the wound care shoe illustrating afitting marker molded on the side of the out sole, and an upper composedof an outer covering and a lining with the outer covering cut away toexpose the lining and remove pressure from an ulcer or other lesionwhile the underlying soft lining remains in place to provide protectionwhile reducing pressure over the lesion. FIG. 2 also illustrates arocker bottom out sole which improves ambulation while reducing weightbearing pressure from the heel and forefoot as well as reducing frictionwithin the shoe from foot movement, and a foam-padded collar designed toreduce pressure and provide comfortable fit around the heel and ankle.

FIG. 3 is a cut-away or cross section of the foot and healing shoeshowing the circumferential counter extending upward from the sole, andfour (4) layers of multi-density insoles, as well as the layer ofpolywood and a metatarsal shank.

FIG. 4 is a longitudinal cross section of the wound care shoeillustrating the insole layers, metatarsal shank within the outsole andcircumferential counter.

FIG. 5A is a cross section of a human foot illustrating the metatarsalsand phalanges of the foot.

FIG. 5B is a cross section of the shoe and foot at the metatarsal headlevel illustrating an altered insole to remove pressure from a plantarlesion of the foot.

FIG. 6 is a side elevation of the wound care shoe showing the oppositeside of the wound care shoe from FIG. 2.

FIG. 7 illustrates the general shape of the out sole in a plantar aspectof the human foot, in conjunction with table 2.

FIG. 8 illustrates the arrangement of the insole layers of the woundcare shoe for treating a specific type of ailment.

FIG. 9 illustrates the arrangement of the insole layers of the woundcare shoe for treating an alternate specific type of ailment.

FIG. 10 illustrates a preferred cut out of at least one insole layer ofthe wound care shoe for treating a wound.

FIG. 11 illustrates the arrangement of the insole layers of the woundcare shoe for treating another alternate type of ailment.

FIG. 12 illustrates the arrangement of the insole layers of the woundcare shoe for treating yet another specific type of ailment.

FIG. 13 illustrates the arrangement of the insole layers of the woundcare shoe for treating still another type of ailment.

DETAILED DESCRIPTION OF THE INVENTION

A sandal or shoe 10 for use by health care professionals in thetreatment of infections, ulcerations, and other conditions of the foot,due to complications of diabetes or other medical conditions such asrheumatoid arthritis, vascular conditions, neuropathy, or due to traumaof the feet from a variety of causes, in which it is desirable toredistribute weight away from the infected or traumatized area to betreated. The design (as shown in FIG. 2) of the sandal or shoe 10includes a molded out sole 100, an upper portion 300, and an adjustableinsole 500.

The shoe is designed to accommodate the use of layers of various insolematerials generally of a microcellular foam, but not limited to such,including without limitation Plastizote (Plastizote is a medicallyinert, high density polyethylene closed cell foam having excellentmemory and impact absorption properties), Ethylene Vinyl Acetate (E VA), Poron (Poron is a impact absorbing open cell cellular urethane foamproduct), or similar material, to offload specific areas of the foot inorder to promote healing of fractures, ulcers or infections when healingmay be delayed by weight bearing pressure on the lesion.

The molded out sole may be constructed from any suitable materialincluding without limitation Ethylene Vinyl Acetate (E V A);polyurethane or other plastic or thermoplastic; rubber, includingthermoplastic rubber (TPR), styrene butadiene rubber and natural rubber;or combination thereof. The out sole includes a base portion and acircumferential counter portion. The circumferential counter is moldedas a part of the out sole extending completely around an upper portionof the circumference of the out sole. The circumferential counterextends upward from the upper surface of the base portion of the outsole, over an upper portion of the shoe from ¼ to 1 inch.

The circumferential counter extends around the circumference of the topportion of the out sole and forms an opening, cavity, depression orpocket that allows the upper portion of the shoe to be conjoined with orcounter sunk into the out sole. This permits extra depth in the upperportion of the shoe in which a variety of insole layers can be placed.The shoe, despite the extra depth, will have a lower profile than theprior art because the extra depth is within the out sole rather than theshoe upper. The cavity within the out sole of the shoe will provide alower profile more like a conventional shoe while at the same timeproviding the extra room necessary to accommodate the multi-densityinsoles or insole layers.

Various types and thickness of insole material such as EVA can be placedin the cavity portion of the out sole of the shoe and may be altered byeither grinding or cutting away particular sections to remove weight orprovide offloading of the specific area of the foot being treated. Thecavity in the out sole permits the application of insole material belowthe level of the top of the circumferential counter thereby providinggreater stability for the (human) foot and preventing the layered insolematerial from shifting as occurs in conventional shoes and particularlyconventional extra depth shoes, if a layered insole is placed in aconventional extra depth shoe where the extra depth (and therefore thelayered insole material) is above the out sole level.

The upper surface of the base portion of the out sole (inside thecavity) has a small rectangular opening or trough to accommodate aplastic or metal shank (metatarsal shank). The metatarsal shank (155),as shown in FIG. 4, begins at a location corresponding approximatelywith the distal ⅓ of the metatarsals (710, as shown in FIG. 5) of ahuman foot (700) encased by the shoe or sandal as viewed from theplantar aspect (near the axial center of the outsole of the shoe), andextends distally (axially) across the metatarsal-phalangel joints(phalanges (750) shown in FIG. 5) of the foot (700) as viewed from theplantar aspect. The metatarsal shank reduces motion in the shoe and inthe corresponding portion of the foot, as well as adds strength to theout sole.

With reference to FIG. 1 the upper 300 of the shoe 10 is closed aroundthe human foot 700 (as shown in FIG. 5) by overlapping inner 310 andouter 320 flaps secured by any of fastening means including but notlimited to: buttons and corresponding button holes, snaps, eyelet holeswith interconnecting laces, or patches of a hook and loop material(e.g., VELCO®). An additional and preferred alternative isinterconnection of the overlapping inner 310 and outer 320 flaps usinghook and loop straps (generally, 380). One strap closes in front of theankle (a first or ankle strap 482) to lock the heel in position toreduce slipping of the heel in the shoe. The second (forefoot) strap 484fastens over the forefoot to hold this portion of the foot in place.Each flap includes a first (ankle) ring 420 corresponding to the anklestrap 482 and a second (forefoot) ring 440 corresponding with theforefoot strap 484. The ankle 420 and forefoot 440 rings are positioneddirectly across (transversely) from one another and the respective strap(482 or 484) is threaded through the respective pair of rings (420 or440) and secured, thereby securing the inner 310 and outer 320 flaps inplace by applied pressure and tension (between the ring pairs).Additionally, the straps 380 may be stitched at intervals 484, to permitshortening of the straps as edema subsides or the bulk of bandages arereduced. The straps are cut in front of the appropriate stitch line 488to prevent fraying of the straps.

As illustrated in FIG. 2, the shoe upper 300 is constructed of an outercovering 340 of leather, canvas, nylon mesh or other suitable materialwith an inner lining 350 of EVA or soft foam material that can be easilyseparated from the outer covering. The inner lining 350 reduces frictionagainst the non-weight bearing surfaces of the foot while providingincreased comfort. This construction allows the removal of a specificsection of the outer covering (as shown at 390 in FIG. 2) over apressure point or lesion leaving the soft, heat or pressure moldableinner lining 350 (EVA), in place over the ulcer or prominence forprotection. There is also a foam-padded collar 370 around the heel andankle portion (heel portion or heel counter 360) of the shoe or sandal10, to prevent pressure from the outer covering 340 material and reduceheel slippage. To assist the health care provider in proper fitting ofthe shoes a fitting marker 270 is molded into the medial side of the outsole 100. The end of the first metatarsal 710 generally should extendslightly in front of the fitting marker 270 to reduce pressure under themetatarsal heads 720 (as shown in FIG. 5) and permit the rocker bottomout sole 160 (as discussed below) to perform properly.

With reference to FIG. 3, the molded out sole 100 of the shoe or sandal10 is designed with a circumferential counter 120 that extends ¼ to 1inch onto the shoe upper 300 above the upper surface 130 of a baseportion 110 of the outsole 100. Imbedded in the base portion 110 of therocker bottom out sole 100 is the metatarsal shank 155, constructed ofmetal, plastic or other suitable material that begins near the distal ⅓of the metatarsals (710, as shown in FIG. 5) extending across themetatarsal-phalangel joints to control motion in that portion of thefoot. This out sole 100 and the circumferential counter 120, are moldedin one piece and designed to add stability to the foot while providingspace for the insole 500 including insole layers (generally, 520) ofinsole material (individually 600, 620, 640, 660), within the out solecavity 140 to prevent shifting of the insole layers 520 and permitoffloading of specific areas of the foot.

The insole layers 600, 620, 640 and 660 are constructed of Ethyl VinylAcetate (EVA) or other suitable material of varying densities. Thecavity (pocket) 140 formed by the circumferential counter 120 alsopresents a lower profile in that the insole layers 520 are confinedwithin the molded out sole 100 below the level of the upper portion ofthe shoe rather than in the shoe upper itself. The poly-wood layer 680,forming the foundation of the insole 500, is about 2 mm thick. Thedurometer (hardness) or relative density of the insole layers 600, 620,640 and 660 are preferably within 5 degrees of the following example ofthe preferred embodiment but are not in anyway limited thereto.

TABLE 1 Insoles Duro- Layer meter Thickness Material 600 26 ¼ in. softEVA or Plastizote 620 29 ⅛ in. high-density foam/soft Poron 640 42 ¼ in.medium-density foam/EVA or Plastizote 660 50 ¼ in. firm-density foam/EVAor Plastizote

With reference to FIG. 4, the layers 520 of insole material 600, 620,640 and 660 and the inventive out sole 100 provide the extra height(depth) necessary (as if these components were actually a part of theout sole) to create a rocker bottom sole. The rocker bottom 160 of theout sole 100 permits easy ambulation while at the same time allowing thepatient to stand on the flat stable mid section 262 of the rocker bottom160 of the out sole 100. The rocker apex 267 of the rocker bottom 160 ofthe out sole 100 is located at (just below) the fitting marker 270 orjust proximal to the metatarsal heads (720, see FIGS. 5A & B) to reducepressure from the metatarsal heads 720 and then tapers off toward thetoe of the out sole in the toe section 261. The heel section 263 of therocker bottom 160 of the out sole 100 is tapered at an oblique anglefrom mid-section 262 to the rear of the rocker bottom 160 of the outsole 100 in a manner to cause heel strike about mid-heel at the obliqueangle 268 between the heel section 263 and mid section 262. The rockerbottom 160 combined with the metal or plastic metatarsal shank 155,allows the patient to ambulate comfortably while reducing motion of thefoot thereby reducing the friction caused by the foot movement withinthe shoe.

Referring now to FIGS. 5A & B, the shoe upper 300 having an inner lining350 and an outer covering 340, as well as the insole layers 520 (600,620, 640 and 660) of EVA, Poron and or other suitable material aredesigned to be altered as shown at 550 (see FIG. 2 at 390 for alterationof the upper), by or under the direction of the health care provider tooffload weight from a specific area 770 of the foot. While the manner inwhich the insoles or shoe need to be altered is a clinical judgment forthe health care provider, a method for altering the shoe is describedhereinafter.

Non-weight bearing ulcers generally occur over the posterior, medial orlateral aspect (on the top (dorsal) portion of the foot as opposed tothe plantar aspect. For non-weight bearing ulcerations, regardless ofgrade (severity), the external cover of the shoe only is removed (seeFIG. 2, element 390) leaving the soft inner lining intact to protect thelesion being treated and reduce the occurrence of window edema. Airholes may be added to the outer covering 340 in order to facilitateouter covering removal in those areas where ulcers are most likely tooccur. Where such air holes are provided, the health care professionaloptimally should pass a small, blunt object (e.g., a large paperclip)from one air hole to the adjacent air hole in the outer covering, beingcareful not the penetrate the inner lining in order to remove aparticular region of the outer covering without damaging the innerlining. Alternately, using a sharp instrument, the health careprofessional should cut away the portion of the outer coveringsurrounding (directly above) the lesion to be treated or between the airholes nearest the lesion in order to remove the required amount of outercovering. The initial cut should be below the level of the top of thearea being removed (dorsally). A flat instrument or tongue depressor maythen be inserted between the covering and the lining to preventaccidental cutting or damage to the lining when the covering is cutaway. Insole layers 520 should optimally be arranged as indicated byFIG. 8 when no open ulcers are present. Should the ulcer or inflammationextend to the plantar surface of the foot, the insoles should be alteredin the same manner as described below for the treatment of plantar(weight-bearing) ulcers.

When treatment of weight-bearing ulcers of grade 0 and 1 on the WagnerScale on the plantar surface of the foot is required, the insole layers520 optimally should be placed in the order as indicated in FIG. 9.Using a sharp instrument such as a scalpel or utility knife, the healthcare professional should cut away an oval area (area to be removed 550)of the medium density insole layer 640 directly under the ulcer as shownin FIG. 5B and FIG. 9. The health care professional should skive theedges to an angle of approximately 30° so that the opening farther awayfrom the foot is slightly larger than the opening nearer the plantarsurface of the foot. The oval relief area should be approximately 0.5 cmlarger than the ulcer and extend distally 1.25 cm as shown in FIG. 10. Ahard, smooth-cutting surface should be used to obtain more accurate andsafe cutting results. After the wound has closed, the insole layersshould be rearranged as indicated in FIG. 11. The shoe can then be usedas a household ambulation slipper.

When treatment of weight-bearing ulcers of grade 2 and above on theWagner Scale on the plantar surface of the foot is required, the insolelayers 520 optimally should be placed in the order as indicated in FIG.12. Using a sharp instrument such as a scalpel or utility knife, thehealth care professional should cut away an oval area 550 of the mediumdensity insole layer 640 and the firm density insole layer 660 directlyunder the ulcer as shown in FIG. 5 (showing only the removal of mediumdensity insole layer 640) and 12. The oval relief area should beapproximately 0.5 cm larger than the ulcer and extend distally 1.25 cmas described previously with respect to FIG. 10. When the oval area iscut away from the medium density insole layer, the firm density insolelayer or both, the opening in the insole should be slightly larger onthe bottom (further from the wound) than the top (nearer the wound) inorder to minimize pressure and shear to the ulcer margin. After thewound has closed, the insole layers should be rearranged as indicated inFIG. 13. The shoe can then be used as a household ambulation slipper.

Proper fitting of the Wound Care shoe is essential for optimal results.To this end, the fitting marker 270 as shown in FIG. 2 is molded intothe out sole 100 to assist in proper fitting. The head of the firstmetatarsal (720 in FIGS. 5A & B) should be positioned such that it isslightly in front of the fitting marker 270 to ensure that the othermetatarsal heads are just in front of the high point (rocker apex 267)of the rocker bottom 160 of the out sole 100 to reduce theweight-bearing load on the metatarsal heads and forefoot.

Additionally, a variety of out sole dimensions are contemplated in orderto accommodate a wide variety of foot shapes and sizes, as illustratedin FIG. 7 and described in table 2, below. All dimensions are incentimeters (cm).

TABLE 2 Out Sole Dimensions A B C Small 26.00  9.25 6.25 Medium 27.0010.25 7.00 Large 28.25 10.50 7.50 X-Large 30.50 11.00 7.50 XX-Large32.00 11.25 7.75

While the present invention and method for using same has been describedusing specific terms and preferred embodiments, such description is forillustrative purposes only, and it is understood that changes andvariations may be made by one skilled in the art without deviating fromthe broad principles and teachings of the present invention which shallbe limited solely by the scope of the claims appended hereto.

1. A medical shoe for use in supporting a patient's foot comprising: anout sole; an upper assembly secured to and partially surrounded by theout sole; an insole assembly substantially enclosed by the out sole andthe upper assembly; the out sole having a base portion generallycorresponding with the plantar aspect of a human foot and of varyingthickness and having a substantially rectangular opening in a topsurface thereof adapted for accommodating a metatarsal shank; the outsole having a circumferential counter portion extending upwardcircumferentially from the top surface of the base portion of the outsole around the base portion of the out sole thereby providing a cavityin the out sole; the upper assembly including a heel portion, anintermediate portion and a toe portion, the heel section andintermediate section integrally connected; the upper assembly adapted tosurround at least the heel, sides and dorsal portions of the human foot;the upper assembly attached to the top surface of the base portion ofthe out sole and the circumferential counter of the out sole, andextending in a dorsal direction from the top surface of the base portionof the out sole along the circumferential counter; the insole assemblyhaving a plurality of insole layers disposed in the out sole cavity andsurrounded by the upper assembly and the out sole circumferentialcounter; the plurality of insole layers provided to include at least oneof a plurality of differing insole layer thickness, materials,hardnesses and densities; wherein each of the plurality of insole layersis separably removable, wherein said plurality of insole layers arestacked on top of one another, and said plurality of insole layers arecapable of being rearranged so as to be stacked in different orders; andwherein the out sole circumferential counter prevents each of theplurality of insole layers from shifting within the out sole cavity whenthe insole layers are stacked in each of the different orders; whereinsaid plurality of separably removable insole layers include at leastthree layers.
 2. The medical shoe as claimed in claim 1, wherein theinsole assembly includes at least a first and a second insole layerwherein the first and second layers are an Ethyl Vinyl Acetate (EVA)material, and the second layer has a durometer less than the firstlayer.
 3. The medical shoe as claimed in claim 2, wherein the openingfor the metatarsal shank is centered laterally and extends distally froma location substantially corresponding to the distal ⅓ of themetatarsals in a plantar aspect of a corresponding foot to be supportedby the medical shoe; and wherein the metatarsal shank accommodatedtherein is comprised of one of a metallic material and a rigid plasticmaterial.
 4. The medical shoe as claimed in claim 3, wherein a bottomsurface of the base portion of the out sole has a unique rocker shape, arocker bottom, adapted to permit easy ambulation while also providing astable platform for standing; the rocker bottom having a flatmid-section in upwardly and rearwardly oblique relation to a taperedheel section and upwardly and forwardly oblique relation to a taperedtoe section.
 5. The medical shoe as claimed in claim 4, wherein the apexof the rocker bottom which is adapted to form the oblique angle betweenthe mid-section and the tapered toe section is located just below afitting marker just proximal to the metatarsal heads, the oblique anglebetween the tapered heel section and the mid-section is located justbelow mid-heel, and the taper of the heel section is adapted so as tocause the heel to strike at the oblique angle between the tapered heelsection and the mid-section.
 6. The medical shoe as claimed in claim 1,wherein the opening for the metatarsal shank is centered laterally andextends distally from a location substantially corresponding to thedistal ⅓ of the metatarsals in a plantar aspect of a corresponding footto be supported by the medical shoe, and wherein the metatarsal shankaccommodated therein is comprised of one of a metallic material and arigid plastic material.
 7. The medical shoe as claimed in claim 6,wherein a bottom surface of the base portion of the out sole has aunique rocker shape, a rocker bottom, adapted to permit easy ambulationwhile also providing a stable platform for standing; the rocker bottomhaving a flat mid-section in upwardly and rearwardly oblique relation toa tapered heel section and upwardly and forwardly oblique relation to atapered toe section.
 8. The medical shoe as claimed in claim 7, whereinthe apex of the rocker bottom which is adapted to form the oblique anglebetween the mid-section and the tapered toe section is located justbelow a fitting marker just proximal to the metatarsal heads, theoblique angle between the tapered heel section and the mid-section islocated just below mid-heel, and the taper of the heel section isadapted so as to cause the heel to strike at the oblique angle betweenthe tapered heel section and the mid-section.
 9. A medical shoe for usein supporting a patient's foot comprising: an out sole; an upperassembly secured to and partially surrounded by the out sole; an insoleassembly substantially enclosed by the out sole and the upper assembly;the out sole having a base portion generally corresponding with theplantar aspect of a human foot and of varying thickness and having asubstantially rectangular opening in a top surface thereof adapted foraccommodating a metatarsal shank; the out sole having a circumferentialcounter portion extending upward circumferentially from the top surfaceof the base portion of the out sole around the base portion of the outsole thereby providing a cavity in the out sole; the upper assemblyincluding a heel portion, an intermediate portion and a toe portion, theheel section and intermediate section integrally connected; the upperassembly adapted to surround at least the heel, sides and dorsalportions of the human foot; the upper assembly attached to the topsurface of the base portion of the out sole and the circumferentialcounter of the out sole, and extending in a dorsal direction from thetop surface of the base portion of the out sole along thecircumferential counter; the insole assembly having a plurality ofinsole layers disposed in the out sole cavity and surrounded by theupper assembly and the out sole circumferential counter; the pluralityof insole layers provided to include at least one of a plurality ofdiffering insole layer thickness, materials, hardnesses and densities;wherein the insole assembly includes at least a first and a secondinsole layer wherein the first and second layers are an Ethyl VinylAcetate (EVA) material, and the second layer has a durometer less thanthe first layer; wherein the insole assembly includes the first andsecond insole layers, and a third and a fourth insole layer wherein thethird layer is a Poron material with a durometer less than the secondlayer and the fourth layer is an EVA material with a durometer less thanthe third layer; and wherein the first, second, third, and fourth layersmay be assembled in any order as determined by a health careprofessional.
 10. The medical shoe as claimed in claim 9, wherein theopening for the metatarsal shank is centered laterally and extendsdistally from a location substantially corresponding to the distal ⅓ ofthe metatarsals in a plantar aspect of a corresponding foot to besupported by the medical shoe; and wherein the metatarsal shankaccommodated therein is comprised of one of a metallic material and arigid plastic material.
 11. The medical shoe as claimed in claim 10,wherein a bottom surface of the base portion of the out sole has aunique rocker shape, a rocker bottom, adapted to permit easy ambulationwhile also providing a stable platform for standing; the rocker bottomhaving a flat mid-section in upwardly and rearwardly oblique relation toa tapered heel section and upwardly and forwardly oblique relation to atapered toe section.
 12. The medical shoe as claimed in claim 11,wherein the apex of the rocker bottom which is adapted to form theoblique angle between the mid-section and the tapered toe section islocated just below a fitting marker just proximal to the metatarsalheads, the oblique angle between the tapered heel section and themid-section is located just below mid-heel, and the taper of the heelsection is adapted so as to cause the heel to strike at the obliqueangle between the tapered heel section and the mid-section.
 13. Themedical shoe as claimed in claim 12, wherein the toe portion of theupper assembly is comprised of one of an open toe portion and a closedtoe portion, the closed toe portion adapted to surround the metatarsaland phalangel portions of the human foot and attached to the baseportion and circumferential counter of the out sole in the same manneras the heel portion and intermediate portion of the upper assembly. 14.The medical shoe as claimed in claim 13, wherein the intermediateportion of the upper assembly includes inner and outer intermediateflaps adapted to cover the dorsal portion of the human foot, andconnection means for interconnecting the inner and outer intermediateflaps.
 15. The medical shoe as claimed in claim 14, wherein theconnection means is comprised of one of buttons and button holes, snaps,hook and loop fastener patches, and holes with corresponding laces. 16.The medical shoe as claimed in claim 15, wherein the connection means iscomprised of straps included a first and a second strap, each of theinner and outer flaps including a first and a second ring attached tothe respective flap with each first and second ring aligned transverselywith one another, and the first and second straps are provided threadedbetween each of the first and second rings respectively to interconnectthe flaps by a pressing and a tension force; the straps comprising oneof fastening mechanisms of hook and loop fasteners, button fasteners andsnap fasteners.
 17. The medical shoe as claimed in claim 10, wherein thetoe portion of the upper assembly is comprised of one of an open toeportion and a closed toe portion, the closed toe portion adapted tosurround the metatarsal and phalangel portions of the human foot andattached to the base portion and circumferential counter of the out solein the same manner as the heel portion and intermediate portion of theupper assembly.
 18. The medical shoe as claimed in claim 17, wherein theintermediate portion of the upper assembly includes inner and outerintermediate flaps adapted to cover the dorsal portion of the humanfoot, and connection means for interconnecting the inner and outerintermediate flaps.
 19. The medical shoe as claimed in claim 18, whereinthe connection means is comprised of one of buttons and button holes,snaps, hook and loop fastener patches, and holes with correspondinglaces.
 20. The medical shoe as claimed in claim 19, wherein theconnection means is comprised of straps included a first and a secondstrap, each of the inner and outer flaps including a first and a secondring attached to the respective flap with each first and second ringaligned transversely with one another, and the first and second strapsare provided threaded between each of the first and second ringsrespectively to interconnect the flaps by a pressing and a tensionforce; the straps comprising one of fastening mechanisms of hook andloop fasteners, button fasteners and snap fasteners.
 21. The medicalshoe as claimed in claim 9, wherein the toe portion of the upperassembly is comprised of one of an open toe portion and a closed toeportion, the closed toe portion adapted to surround the metatarsal andphalangel portions of the human foot and attached to the base portionand circumferential counter of the out sole in the same manner as theheel portion and intermediate portion of the upper assembly.
 22. Themedical shoe as claimed in claim 21, wherein the intermediate portion ofthe upper assembly includes inner and outer intermediate flaps adaptedto cover the dorsal portion of the human foot, and connection means forinterconnecting the inner and outer intermediate flaps.
 23. The medicalshoe as claimed in claim 22, wherein the connection means is comprisedof one of buttons and button holes, snaps, hook and loop fastenerpatches, and holes with corresponding laces.
 24. The medical shoe asclaimed in claim 23, wherein the connection means is comprised of strapsincluded a first and a second strap, each of the inner and outer flapsincluding a first and a second ring attached to the respective flap witheach first and second ring aligned transversely with one another, andthe first and second straps are provided threaded between each of thefirst and second rings respectively to interconnect the flaps by apressing and a tension force; the straps comprising one of fasteningmechanisms of hook and loop fasteners, button fasteners and snapfasteners.
 25. A medical shoe for use in supporting a patient's footcomprising: an out sole; an upper assembly secured to and partiallysurrounded by the out sole; an insole assembly substantially enclosed bythe out sole and the upper assembly; the out sole having a base portiongenerally corresponding with the plantar aspect of a human foot and ofvarying thickness and having a substantially rectangular opening in atop surface of the base portion thereof adapted for accommodating ametatarsal shank; the opening for the metatarsal shank centeredlaterally and extending distally from a location substantiallycorresponding to the distal ⅓ in a plantar aspect of the metatarsals ofthe foot to be supported by the medical shoe, and the metatarsal shankaccommodated therein is comprised of one of a metallic material and arigid plastic material; the out sole having a circumferential counterportion extending upward circumferentially from the top surface of thebase portion thereof around the base portion of the out sole therebyproviding a cavity in the out sole; the upper assembly adapted tosurround at least the heel, sides and dorsal portions of the human foot,the upper assembly including a heel portion, an intermediate portion anda toe portion, the heel portion and intermediate portion integrallyconnected, the toe portion comprised of one of an upper toe portion anda closed toe portion, the closed toe portion adapted to surround themetatarsal and phalangel portions of the human; the upper assemblyattached to the top surface of the base portion of the out sole and thecircumferential counter of the out sole, and extending in a dorsaldirection from the top surface of the base portion of the out sole alongthe circumferential counter; the insole assembly having a plurality ofinsole layers disposed in the out sole cavity and surrounded by theupper assembly and the out sole circumferential counter; the pluralityof insole layers provided to include a first insole layer, a secondinsole layer a third insole layer and a fourth insole layer wherein thefirst and second layers are an Ethyl Vinyl Acetate (EVA) material andthe second layer has a durometer less than the first layer, the thirdlayer is a Poron material with a durometer less than the second layer,and the fourth layer is an EVA material with a durometer less than thethird layer, and the first, second, third, and fourth layers may beassembled in any order as determined by a health care provider; the baseportion of the out sole having a rocker bottom surface, adapted topermit easy ambulation while also providing a stable platform forstanding, the rocker bottom having a flat mid-section in upwardly andrearwardly oblique relation to a tapered heel section and upwardly andforwardly oblique relation to a tapered toe section, the apex of therocker bottom adapted to form the oblique angle between the mid-sectionand the tapered toe section and located just below a fitting marker justproximal to the metatarsal heads, the oblique angle between the taperedheel section and the mid-section located just below mid-heel, the taperof the heel section adapted so as to cause the heel to strike at theoblique angle between the tapered heel section and the midsection, theintermediate portion of the upper assembly including inner and outerintermediate flaps adapted to cover the dorsal portion of the humanfoot, and a first and second strap adapted for using a hook and loopfastening mechanism for interconnecting the inner and outer intermediateflaps, each of the inner and outer flaps including a first and a secondring attached to the respective flap with each first and second ringaligned transversely with one another, and the first and second strapsare provided threaded between each of the first and second ringsrespectively to interconnect the flaps by a pressing and a tensionforce.
 26. A method, comprising providing the medical shoe of claim 25;and fitting the shoe such that the head of the first metatarsal of thehuman foot is positioned slightly in front of the fitting marker of theout sole to ensure that the other metatarsal heads of the human foot arejust in front of the rocker apex of the rocker bottom of the out sole toreduce a weight-bearing load on the metatarsal heads and forefoot. 27.The method of claim 26, further comprising treating a non-weight bearingarea by removing a portion of the external cover of the upper portion ofthe shoe surrounding and directly above the area to be treated withoutremoving or damaging the soft inner lining so that the area beingtreated is protected.
 28. The method of claim 26, further comprisingtreating a weight bearing area by removing an oval area of at least oneof the insole layers directly under the area to be treated, wherein theedges of oval area are skived to an angle of approximately 30° so thatthe opening farther away from the area to be treated is slightly largerthan the opening nearer the area to be treated, and the upper limit ofthe oval area is approximately 0.5 cm larger than the area to be treatedand extends distally 1.25 cm from the area to be treated.
 29. A method,comprising providing the medical shoe of claim 25; and treating anon-weight bearing area by removing a portion of the external cover ofthe upper portion of the shoe surrounding and directly above the area tobe treated without removing or damaging the soft inner lining so thatthe area being treated is protected.
 30. A method, comprising providingthe medical shoe of claim 25; and treating a weight bearing area byremoving an oval area of at least one of the insole layers directlyunder the area to be treated, wherein the edges of oval area are skivedto an angle of approximately 30° so that the opening farther away fromthe area to be treated is slightly larger than the opening nearer thearea to be treated, and the upper limit of the oval area isapproximately 0.5 cm larger than the area to be treated and extendsdistally 1.25 cm from the area to be treated.
 31. An assembly of ahealing shoe having an upper assembly, an out sole assembly with acavity therein, and an out sole circumferential counter, comprising: aplurality of separably removable insole layers disposed in the out solecavity; the separably removable insole layers surrounded by the upperassembly and the out sole circumferential counter integrally attached tothe out sole assembly and the upper assembly, the insole assemblyincluding an oval opening within at least one of the insole layersadapted to be directly under an area of a human foot; the plurality ofseparably removable insole layers provided to include at least one of aplurality of differing insole layer thickness, materials, hardnesses anddensities, wherein said insole layers are stacked on top of one another,and said insole layers are capable of being rearranged so as to bestacked in different orders; and wherein the out sole circumferentialcounter prevents each of the plurality of insole layers from shiftingwithin the out sole cavity when the insole layers are stacked in each ofthe different orders; wherein said plurality of separably removableinsole layers include at least three layers.
 32. The assembly of claim31, wherein edges of the oval opening are skived such that the openingfarther away from the area to be treated is slightly larger than theopening nearer the area to be treated.
 33. A healing shoe for use insupporting a patient's foot comprising: an out sole; a circumferentialcounter portion attached to and extending upward circumferentially fromthe out sole; a fitting marker provided on a side surface of the outsole for fitting of the healing shoe to a human foot, said fittingmarker being molded into the side surface of the out sole and beingprovided below the circumferential counter.
 34. The healing shoe ofclaim 33, wherein the fitting marker is provided on the medial sidesurface of the out sole approximately ⅓ the longitudinal distancebetween a front surface of a tapered toe section of the shoe and rearsurface of a tapered heel section of the shoe corresponding with an apexof a bottom surface of the of the out sole between a flat mid-section ofthe bottom surface and the tapered toe section in upwardly and forwardlyoblique relation the flat mid-section, the fitting marker is providedfor longitudinal positioning of a metatarsal-phalangel joint of thehuman foot within the healing shoe.
 35. A method, comprising providingthe healing shoe of claim 34, wherein at least one additional insolelayer may be added in the vicinity of an area of the human foot to betreated, the at least one additional insole layer having at least one ofan insole layer thickness, material, hardness and density different fromthe plurality of insole layers of the insole assembly.
 36. A method,comprising providing the healing shoe of claim 33; and fitting thehealing shoe such that a head of a first metatarsal of a human foot ispositioned slightly in front of the fitting marker provided on thesurface of the out sole to ensure that other metatarsal heads of thehuman foot are just in front of a rocker apex of a rocker bottom of theout sole assembly to reduce a weight-bearing load on the metatarsalheads and a forefoot.
 37. A method, comprising providing the healingshoe of claim 33; and fitting the healing shoe such that a head of afirst metatarsal of a human foot is positioned slightly in front of thefitting marker provided on the surface of the out sole assembly toensure that other metatarsal heads of the human foot are just in frontof a rocker apex of a rocker bottom of the out sole assembly to reduce aweight-bearing load on the metatarsal heads and forefoot.
 38. A healingshoe having an upper assembly, an out sole assembly with a cavitytherein, and an out sole circumferential counter, comprising: an insoleassembly disposed in the out sole cavity having a plurality of distinctinsole layers; the insole assembly surrounded by the upper assembly andthe out sole circumferential counter integrally attached to the out soleassembly and the upper assembly and extending upward circumferentiallyfrom the out sole assembly; each of the plurality of insole layersincluding at least one of a plurality of differing insole layerthickness, materials, hardnesses and densities; and a fitting markerprovided on a side surface of the out sole assembly, said fitting markerbeing molded into the side surface of the out sole and being providedbelow the circumferential counter.